Lannett (LCI) Receives FDA Notice of Intention to Withdraw Methylphenidate HCl ER Tablets ANDA; Offers Commentary
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Lannett Company, Inc. (NYSE: LCI) received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. FDA's proposal includes an opportunity for Lannett to request a hearing on this matter.
"We remain confident that our Methylphenidate ER products are safe and effective," said Arthur Bedrosian, chief executive officer of Lannett. "Accordingly, we intend to review the scientific rationale for FDA's most recent position and compile the scientific evidence to convince FDA's Office of Generic Products that our product should continue to be marketed. This will preserve patient and prescriber choice, and maintain an affordable alternative drug on the market to treat attention deficit and hyperactivity disorder."
Lannett has until November 17, 2016 to request the hearing and until December 19, 2016 to submit all data, information and analyses upon which the request for a hearing relies.
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